The purpose of this study is to examine the safety and effectiveness (how well the drug works) of two different doses (3 mg/kg and 10 mg/kg) of Ipilimumab (Yervoy™) in patients with metastatic castration resistant prostate cancer.
Prostate Cancer Clinical Trials Working Group 2 (PCWG2) Response Evaluation Criteria In Solid Tumors (RECIST)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
82
Radiographic Progression-free Survival (rPFS)
rPFS was defined as the time from the date of randomization until the date of disease progression based on radiographic evidence and/or death from any cause, whichever occurs first. Radiographic disease progression is defined as: Confirmed bone disease progression according to criteria adapted from the Prostate Cancer Clinical Trials Working Group 2 (PCWG2), OR Non-bone disease progression according to the modified Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported radiographic progression is shown.
Time frame: From date of randomization until disease progression or death (assessed up to December 2016, approximately 24 months)
Number of Participants Who Experienced Immune-related Adverse Events (irAEs)
The total number of participants with immune-related adverse events of any grade is reported for each arm.
Time frame: From first dose of ipilimumab to last dose plus 90 days
Overall Survival (OS)
OS was defined as the time from the date of randomization until the date of death. For those participants who have not died, OS was censored at the last date the participant was known to be alive. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The total number of reported deaths is shown.
Time frame: From randomization to death from any cause (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Progression-free Survival (PSA PFS)
Prostate specific antigen progression-free survival (PSA PFS) was defined as the time from randomization to the earliest date of PSA progression or death, whichever occurs earlier. Participants who did not progress or die were censored at the last PSA assessment date. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants with reported PSA progression is shown.
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San Francisco Oncology Associates
San Francisco, California, United States
George Washington University Medical Center
Washington D.C., District of Columbia, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Cancer Center Of Kansas
Wichita, Kansas, United States
North Mississippi Med Center
Tupelo, Mississippi, United States
Nebraska Cancer Specialists
Omaha, Nebraska, United States
Providence Portland Medical Center
Portland, Oregon, United States
Northwest Cancer Specialists, Pc
Tualatin, Oregon, United States
University of Pittsburgh Cancer Institute Cancer Services
Pittsburgh, Pennsylvania, United States
Texas Oncology
Houston, Texas, United States
...and 33 more locations
Time frame: From randomization to the earliest date of PSA progression or death, whichever comes earlier (assessed up to December 2016, approximately 24 months)
Time to Pain Progression
Pain progression was defined as an increase in BPI-SF pain Item #3 score of \>= 2 point from baseline maintained over 2 consecutive periods. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment, and presented efficacy results are based on limited data. The number of participants with reported pain progression is shown.
Time frame: From randomization until pain progression (assessed up to December 2016, approximately 24 months)
Prostate Specific Antigen Response Rate
PSA response rate was defined as the proportion of participants with a 50% or greater decrease from baseline to the lowest post-baseline PSA result (confirmed 3 weeks later) for each randomized arm. After termination of the study, collection of tumor assessments and other data to support the efficacy analyses was no longer required in patients who discontinued study treatment. As a result, the presented efficacy results are based on limited data. The number of participants showing PSA response is shown.
Time frame: From baseline to PSA response (assessed up to December 2016, approximately 48 months)